The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial

MATHUR, A., F. FERNANDEZ-AVILES, J. BARTUNEK, A. BELMANS, F. CREA, S. DOWLUT, M. GALINANES, M. C. GOOD, J. HARTIKAINEN, C. HAUSKELLER, S. JANSSENS, Petr KALA, J. KASTRUP, J. MARTIN, P. MENASCHE, R. SANZ-RUIZ, S. YLA-HERTTUALA a A. ZEIHER. The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial. Online. European heart journal. Oxford: Oxford University Press, 2020, roč. 41, č. 38, s. 3702-3710. ISSN 0195-668X. Dostupné z: https://dx.doi.org/10.1093/eurheartj/ehaa651. [citováno 2024-04-23]

Základní údaje

• Originální název: The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial
• Autoři: MATHUR, A. (garant), F. FERNANDEZ-AVILES, J. BARTUNEK, A. BELMANS, F. CREA, S. DOWLUT, M. GALINANES, M. C. GOOD, J. HARTIKAINEN, C. HAUSKELLER, S. JANSSENS, Petr KALA (203 Česká republika, domácí), J. KASTRUP, J. MARTIN, P. MENASCHE, R. SANZ-RUIZ, S. YLA-HERTTUALA a A. ZEIHER
• Vydání: European heart journal, Oxford, Oxford University Press, 2020, 0195-668X.

Další údaje

• Originální jazyk: angličtina
• Typ výsledku: Článek v odborném periodiku
• Obor: 30201 Cardiac and Cardiovascular systems
• Stát vydavatele: Velká Británie a Severní Irsko
• Utajení: není předmětem státního či obchodního tajemství
• WWW: URL
• Impakt faktor: Impact factor: 29.983
• Kód RIV: RIV/00216224:14110/20:00117708
• Organizační jednotka: Lékařská fakulta
• Doi: http://dx.doi.org/10.1093/eurheartj/ehaa651
• UT WoS: 000593017200010
• Klíčová slova anglicky: ST-elevation myocardial infarction; Cell- and tissue-based therapy; Bone marrow cells
• Štítky: 14110211, rivok
• Příznaky: Mezinárodní význam, Recenzováno

Anotace

Aims Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. Methods and results Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, <45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group. Conclusions Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results. [GRAPHICS] .